Injections of SVF in Ankle Osteoarthritis

Istituto Ortopedico Rizzoli

Status: Completed

Conditions: Ankle Osteoarthritis

Treatments: Procedure: SVF injection

Study type: Interventional

Funder types: Other

Identifiers

NCT04998162

ADSCs-INT

Details and patient eligibility

About

The aim of this pilot study is to analyze the effect of SVF injection produced by adipose tissue processing, in terms of clinical improvement, in patients with moderate to severe (stage 1-3) ankle osteoarthritis. Evaluation will be performed by administering pre-operative and post-operative clinical assessment questionnaires.

Patients will be followed-up with a pre-operative evaluation and post-operative evaluations at 30 days, 3-6-12, and 24 months after application.

Full description

30 patients with moderate to severe ankle osteoarthritis (grade 1-3 according to Giannini's classification) will be included in this pilot study, in which patients will be treated with single injection of Stromal Vascular Fraction - SVF ,obtained by processing the patient's abdominal adipose tissue. All patients will be examined with a baseline clinical visit. For obtaining SVF, will be carried out a routinely performed procedure aimed at obtaining a small amount of adipose tissue from all patients. Subsequently, patients will be followed up with clinical evaluation at 1, 3, 6, 12 and 24 months.

Enrollment: 30 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients suffering from moderate to severe unilateral ankle arthrosis (grade 1-3 according to Giannini's classification);
2. Patients who gave written informed consent to participate in the study;
3. .Patients with MRI examination showing absence of osteochondral lesion;
4. Patients who have given their willingness to come to the Institute for follow-up visits

Exclusion criteria

1. Patients with BMI>30 kg/m2
2. Patients with Rheumatoid Arthritis
3. Patients with chronic inflammatory joint disease;
4. Patients with acute or chronic infections;
5. Patients with pre-existing abnormalities of gait kinematics (amputations, neuro-muscular diseases, poliomyelitis, hip dysplasia);
6. Patients with severe knee arthrosis (Kellgren-Lawrence>3);
7. Patients with ankle deformities greater than 8°;
8. Patients with pain on other joints of the foot;
9. Patients with severe postural instability;
10. Patients with cognitive deficits;
11. Patients with concomitant neurological pathologies

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

SVF injection

Experimental group

Description:

All patients with ankle osteoarthritis will be treated with a single injection of SVF, obtained from the patient's abdominal adipose tissue. All patients will be examined with a baseline clinical visit and will be followed-up with clinical evaluation at 1, 3, 6, 12 and 24 months.

Treatment:

Procedure: SVF injection